Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Consolidated Chemicals, LLC
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
HAND SANITIZER- ISOPROPYL ALCOHOL GEL CONSOLIDATED CHEMICALS, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- HAND SANITIZER GEL HAND SANITIZER GEL This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry. An inactive ingredient (Hydroxypropyl methylcellulose) has been added to increase the viscosity of hand sanitizer. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations and addition of hydroxypropyl Methylcellulose (inactive ingredient added to increase product viscosity): a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol (1.45% v/v). c. Hydrogen peroxide (0.125% v/v). d. Sterile distilled water or boiled cold water. e. Hydroxypropyl Methylcellulose USP (0.5% w/v) ACTIVE INGREDIENT(S) Isopropyl Alcohol 75% v/v. Purpose: Antiseptic PURPOSE Antiseptic, Hand Sanitizer USE Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. WARNINGS For external use only. Flammable. Keep away from heat or flame DO NOT USE in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritat Przeczytaj cały dokument